MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number CQF7574

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported inflation and material rupture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model cqf7574 pta balloon dilatation catheter allegedly inflation problem and material rupture.The information was received from a single source.One patient was involved with no reported patient injury.The (b)(6) year old female patient was (b)(6) kgs.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model cqf7574 pta balloon dilatation catheter allegedly inflation problem and material rupture.The information was received from a single source.One patient was involved with no reported patient injury.The 57 year old female patient was 50 kgs.

Manufacturer Narrative

H10: for the reported malfunctions, reportability was reassessed and determined to be no longer reportable.H10: the lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported inflation and material rupture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10749764
• MDR Text Key: 213505456
• Report Number: 2020394-2020-06176
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060496
• UDI-Public: (01)00801741060496
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CQF7574
• Device Catalogue Number: CQF7574
• Device Lot Number: REDP2500
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1